Committee E55. Introduction

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1 Introduction...1 E55 Subcommittee Reports...2 Standards Roadmapping...4 Outreach Strategies...5 Membership Updates...6 Effective Participation Tips...8 Introduction Committee E55 Welcome to another ASTM E55 Committee Newsletter! Since our last issue, E55 held a successful workshop in Lausanne, Switzerland, on future standards development. This complemented the input received from the workshop hosted by FDA in 2016 and included European regulatory counterparts from WHO and IFPMA. You ll find more details on this inside the newsletter. Another exciting development for E55 is the creation of the E55.05 subcommittee on Lyophilization, which was one of the areas identified for future standards development based on survey feedback from E55 members. Details on the scope of this new subcommittee can be found on page 4. As we anticipated in the summer 2017 Newsletter, a new E55 chair, vice chair, recording and membership secretaries for were elected. Graham Cook served the maximum three terms as chairman of E55, and Ferdinando Aspesi and Russ Madsen were elected as E55 chair and E55 vice chair respectively. Don Kientzler was re-elected as recording secretary and Paul Gill as membership secretary. During the time that Graham served as chairman, E55 has grown significantly, with the creation of the E55.04 and E55.05 subcommittees, increased focus on outreach and successful engagement with key regulators including FDA, EMA, and WHO. But most importantly, it is through the efforts of E55 members to develop and review all the 20+ and counting E55 standards. As always, any comments or topics for future issues of the newsletter are welcome and can be sent to Travis Murdock (ASTM Staff Manager, Technical Committee E55; tmurdock@astm.org). Best wishes for 2018! Graham Cook PhD Past Chairman Ferdinando Aspesi PhD Chairman Russell Madsen Vice Chairman Page 1

2 E55 Subcommittee Reports Planning for Success In 2017, Committee E55 once again made strides towards revising and expanding its existing catalog of standards. The following subcommittee reports highlight each group s accomplishments and ongoing efforts in standards development. We encourage members and interested industry stakeholders to join these efforts by reaching out to the subcommittee chairmen. E55.01 Process Understanding and PAT System Management, Implementation and Practice Chair: Martin Warman, Martin Warman Consultancy Ltd Since the spring issue of the E55 Newsletter, the main activities within E55.01 have been the work to address the negatives found persuasive on both WK51471 (revision of E Standard Guide for Application of Continuous Processing in the Pharmaceutical Industry) and WK41265 (New Practice for Sampling). For WK51471, resolutions have been found and the revised draft will go to ballot early in For WK41265, the technical contact, Lou Traglia, Commissioning Agents Inc., is working through the outstanding negatives. The work of the group is no easy task, as many of the ballot responses submitted on behalf of a larger companies often represent differing views of several individuals within that organization. The task group continues to make strides on the various comments and plans to send a revised draft to ballot later in Since the last issue of the newsletter, two new activities have started within E A review of ASTM E Standard Guide for Multivariate Data Analysis in Pharmaceutical Development and Manufacturing Applications was completed and it was decided a revision is needed. A new work item is registered and a collaboration area is being set up to allow participation. Also WK57018 (revision of E Standard Guide for Verification of Process Analytical Technology (PAT) Enabled Control Systems) is nearing completion and also will go to ballot. Any members who wish to be part of any of these two activities are welcome to make contact with either Martin or Benoit Igne (GSK) who are the technical leads. E55.03 General Pharmaceutical Standards Chair: Claus Weisemann, Luitpold Pharmaceuticals Subcommittee E55.03 saw significant progress across many of its active projects over the course of A major milestone project that was completed was former work item WK The task group worked diligently to develop, resolve negatives, and approve the new E3077 Standard Guide for Raw Material edata Transfer from Material Suppliers to Pharmaceutical & Biopharmaceutical Manufacturers. The standard, as well as its supporting XSD and XML schema files, has been well received since being published last year. Now that it has been adopted by the industry, the task group leaders have been gathering feedback and plan to make improvements to standard in the New Year. Another major work item from E55.03 is nearing completion. WK15778 New Guide for Science-based and Riskbased Cleaning Process Development and Validation finished the approval process in late The task group was successful in resolving many of the negative comments. The new guide has finished the ASTM approval process and is currently being edited for publication. It is expected to be released later in Q1 of Page 2

3 Other open projects for the subcommittee include: The drafting of a new standard, WK52609 Standard Guide for Validating End-user Sterilizing Filtration of Pharmaceutical, Biopharmaceutical, and Biological Products; The review and reapproval of E2537 Standard Guide for Application of Continuous Process Verification to Pharmaceutical and Biopharmaceutical Manufacturing; The beginning of the review process for E2500 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment as well as E2504 Standard Practice for Qualification of Basked and Paddle Dissolution Apparatus, both of which are coming up on their 5 th year since approval. E55.04 General Biopharmaceutical Standards Chair: Bob Steininger, Voyager Therapeutics The present focus of E55.04 subcommittee continues to be on developing standards for single use equipment and for viral removal/inactivation. The work on extractables from single use equipment now focuses on assays to determine the amount of extractables and will try to leverage existing ASTM extractable standards for plastics. A new standard focused on the extraction and isolation of particulates from single use equipment (WK54630) is being drafted and is available for review in the ASTM Collaboration Area. The subcommittee is also working on two standards related to the characterization of particulate matter from single use equipment. The goal is to bring these draft standards to the balloting process in A new task group has been formed to move forward the viral filtration standard for large viruses. Should any members of E55 or interested stakeholders wish to learn more or participate in any of these efforts, they are encouraged to reach out to the subcommittee chair. Finally, in addition to the current open activities, a proposal for a new standard on continuous manufacturing of biopharmaceuticals has been brought forward and will likely be a big focus of the subcommittee for Page 3

4 Standards Roadmapping New Subcommittee on Lyophilization Executive Subcommittee Approves formation of E55.05 on Lyophilization Committee E55 is proud to announce the formation of its newest subcommittee, E55.05 on Lyophilization. This new group was proposed to the E55.05 executive subcommittee by the Advanced Lyophilization Technology Consortium, LyoHub, based on their work developing best practices related to lyophilization process instrumentation, equipment qualification, and scale-up. LyoHub is championed by Purdue University after being awarded the National Institute of Standards and Technology (NIST) Advanced Manufacturing Technology Consortia (AMTech) grant in Following a recent meeting at NIST, colleagues from FDA advised the group to consider using their best practices as a basis for creating consensus standards, recommending ASTM Committee E55 as a logical landing place. The proposal to form the new subcommittee was met with wide support from Committee E55 as lyophilization was considered a topic of high interest based on the results of the recent Areas of Focus Roadmap survey conducted in early During the December executive subcommittee meeting, the subcommittee was approved with the following scope; E55.05 Lyophilization subcommittee of E55 committee: The scope of this sub-committee is to develop, disseminate and educate standard practices and guides relevant to lyophilization of parenterals and other pharmaceutical and biological products. The work of the subcommittee will cover all aspects of process and equipment design, operation and qualification, quality assessment, process understanding and control. The new subcommittee will be led by Dr. Arnab Ganguly, Technology Manager at IMA Life. Anyone with interest in joining this new group is invited to do so through their MyASTM account, or by contacting the E55 Staff Manager, Travis Murdock, at tmurdock@astm.org. E55.95 Roadmap for Standards Development Chair: Louis Traglia, Commissioning Agents Inc. As was reported in the previous issue of the E55 Newsletter, the E55.95 administrative subcommittee on the roadmap for standards development issued a survey to committee members to determine the topic areas of focus. The results of the survey provided the subcommittee with a range of topics of high interest for potential new standards. Recognizing that the survey only provided direction and little feedback with regards to specific needs, sub teams were established to investigate needs and resources around areas such as continuous manufacturing, characterization of new molecules, risk assessment for single use systems, subvisible particles, gene and cell therapy, supply chain, aseptic practices, and lastly, lyophilization, which has already resulted in the creation of the new E55.05 subcommittee. Lou Traglia is overseeing the work of the sub teams with E55 members with expertise in the various topics leading the different groups. The E55.95 subcommittee plans to meet again during the April 2018 committee meeting. Anyone interested in participating should contact Lou at Louis.Traglia@cagents.com. Page 4

5 Outreach Strategies Reaching the Global Community E55 Continues Forging International Partnerships As a way to engage our international members, E55 requires that it conduct its semi-annual in person meetings outside of the United States every other year. So to address this requirement, in October 2017, the committee jumped on an invite to hold its international meeting at the École polytechnique fédérale de Lausanne (EPFL) Innovation Park in Lausanne, Switzerland, compliments of colleagues at AC Immune SA. Meeting organizers took this opportunity to invite European industry stakeholders from the World Health Organization (WHO) and the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA), who in turn sent representatives to participate in a joint workshop with ASTM E55. The workshop included presentations and discussions on current scientific practices and industry trends and how E55 can help provide solutions for the industry through voluntary consensus standards. The workshop was well received by those in attendance. Presenters and topics included; Sabine Kopp, Group Lead for Medicines Quality Assurance at WHO, who presented on the WHO Expert Committee on Specifications for Pharmaceutical Preparations; Isabelle Colmagne-Poulard, Senior Director of Regulatory CMC at Merck KGaA, who presented on behalf of IFPMA; and Graham Cook, Pfizer, E55 Chairman, who presented an overview of the ASTM process and Committee E55. Following the presentations, speakers and the audience participated in an open discussion around issues of importance to the industry and how each organization could address those concerns. As a result of the workshop, E55 and WHO agreed to an informal liaison to keep both sides informed on topics of interest; IFPMA representatives agreed to share awareness of E55 to their membership and consider the establishment of a formal partnership between the two professional organizations. Save the Date: Spring 2018 E55 Meeting and Workshop Still running on the positive outcomes from the Lausanne meeting, E55 has been working hard on planning its next committee meeting and workshop event. Courtesy of committee members associated with Amgen, meeting space has been reserved for April at the Kendall Square facility in Cambridge, Massachusetts. The event will kick off with a workshop on Emerging Technologies in Biopharmaceutical Manufacturing, and will focus on identifying the areas of uncertainty and concern for emerging technologies, with the aim of developing best practices and consensus standards as guidance for manufacturers and regulators alike. This is an excellent opportunity to meet with industry peers and regulators to highlight topics and advance understanding on a novel emerging technology. For more information, contact the workshop chairman, Duncan Low at dlow@amgen.com Page 5

6 Membership Updates Colleagues in Industry Welcome new E55 Committee Officers for As defined in the ASTM International Regulations Governing Technical Committees, as well as the By-Laws for Committee E55, the Executive Subcommittee established a Nominating Committee to generate a slate of main committee officers to fill a selection of officer roles for the term. Terms for committee officers last two years with a limit of three consecutive terms. The slate of officers was then sent to ballot for approval from E55 members. The following officers were elected as a result of the ballot: Position Name Organization Chairman Ferdinando Aspesi Bridge Associates International LLC Vice Chairman Russell E. Madsen The Williamsburg Group, LLC Recording Secretary Donald C. Kientzler Consultant Membership Secretary Paul J. Gil Sparks Therapeutics Member Spotlight - Awards In recognition of the hard work of two E55 members, Tony Wang and Ting Wang of Amgen (pictured along with Alison Moore, SVP Process Development at Amgen) were granted an Award of Appreciation for their contributions and dedication to the development of E Standard Guide for Raw Material edata Transfer from Material Suppliers to Pharmaceutical & Biopharmaceutical Manufacturers. Their tireless effort as leaders of the task group and throughout the development and approval process led to the completion of a new standard guide that is aimed to aid in the transfer all elements of raw material electronic data from suppliers to customers. This standard was developed to aid pharmaceutical and biopharmaceutical manufacturers, but could be applicable beyond the industry. ASTM International committees present Technical Committee Awards, which are administered throughout the year at the discretion of the committee, usually during committee meetings or other appropriate functions. These awards may be given to show appreciation for outstanding service to the committee or subcommittee, outstanding contributions to the development of a standard or group of standards and to show appreciation for a specific service. Page 6

7 Directly Impacting the Content of your Standards The current E55 membership roster has over 180 subject matter experts from around the world. Countries represented are as follows: Belgium; Canada, China; Denmark; France; Germany; Ireland; Japan; Mexico; Nepal; Peru; Portugal; Singapore; Sweden; Switzerland; UK; USA. Welcome new members of the E55. Your participation in the technical committee allows you to directly impact the content of the standards. Members on the list below have joined E55 are new members in the last 6 months. New Member Pena, Karen Ghimire, Ajaya Franks, Stephen H Aysola, Manjula Lovsin-Barle, Ester New Member Orientation Organization Amgen T M Electronics Inc MilliporeSigma Lonza Vergara Sanchez, Angela Centro Nacional de Recursos Estrategicos de Salud-CENARES Alexeenko, Alina Shannon, Frank LePage, Matt Moore, Keith Kenney, Jonathan Badding, Melissa Purdue University/LyoHUB Interface Biologics Inc. IMR Test Labs ICLS GE Not a Member? Here s How to Get Involved Exponent, Inc. Any individual or organization from any country with interests in the pharmaceutical and biopharmaceutical industry are welcome to join Committee E55 and share your ideas. Existing ASTM International members can join E55 via their MyASTM account page. If you are not already an ASTM member, all you need to do is complete an application at Should you ever have any questions regarding the organization, the committee, or standards in general, do not hesitate to contact our E55 Staff Manager, Travis Murdock, at tmurdock@astm.org. Page 7

8 Effective Participation Tips Maximize Your Investment Proactive Participation After joining your committee(s), we encourage you to be proactive - build a foundation of knowledge and engage with the committee leadership. Here is some key information to get you started: Initial Training We offer live online training year-round, as well as face-to-face training at most technical committee meetings. The sessions provide information on navigating our website and the standards development process, and include situational questions and solutions. We recommend participation in the New Member Orientation and Balloting and Handling Negatives Votes sessions. Who s Who? View member training topics and upcoming sessions at All ASTM committees are staffed with a Committee Chairman (elected), Committee Manager and Administrative Assistant who act as resources for any questions you may have. Introduce yourself to the Chairman or Committee Manager at a meeting, by phone or . Meetings Attendance at ASTM committee meetings is not required; however, it is one of the most effective ways to engage the process and have the opportunity to network with industry colleagues. Most committees meet face-to-face twice per year, hold teleconferences and communicate via throughout the year. These are the forums at which decisions are made. Scheduled committee meetings are listed on our website. They are free to attend and online preregistration is available. Website Navigational Videos Click here: Self-Manage ASTM s - Short Video Click here: Other Tools: ASTM Regulations ASTM Form & Style Manual How Standards Get Developed Page 8